Type 2 Diabetes MellitusNCT00680849
Enhancing Support for Women With Type 2 Diabetes: Follow-Up
An observational study of Type 2 Diabetes Mellitus, run by Oregon Research Institute at 1 site in United States.
Trial summary
This study is a 5-year continuation of "The Mediterranean Lifestyle Program." The purpose of this follow-up study is to determine the long-term effects from prior participation in an intervention promoting healthful eating, exercise, quitting smoking, stress management, and social support. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women only
- Conditions the study is for
- Type 2 Diabetes Mellitus
- How many people
- 227 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Participants in prior study: Enhancing Support for Women With Type 2 Diabetes, "The Mediterranean Lifestyle Program."
Inclusion Criteria: All participants in the original study are eligible. The inclusion criteria for the original study were:
- diagnosis of type 2 diabetes for at least 6 months
- being post-menopausal
- living independently (e.g., not in an institution or nursing home)
- having a telephone
- ability to read English
- not being developmentally disabled, and
- living within 30 miles of the Eugene-Springfield metropolitan area.
Exclusion Criteria: Exclusion criteria for the original study included:
- being older than 75 years of age
- having life-threatening illnesses, or
- planning to move from the local area within the time span of the study.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a 5-year continuation of "The Mediterranean Lifestyle Program." The purpose of this follow-up study is to determine the long-term effects from prior participation in an intervention promoting healthful eating, exercise, quitting smoking, stress management, and social support. Participants are post-menopausal women with type 2 diabetes.
Read the detailed description
Coronary heart disease (CHD) is the leading cause of death and functional limitations among women in the U.S. Postmenopausal women with diabetes are at especially high risk of CHD, but CHD research with this population is very limited. This project addresses the poorly understood "natural history" of long-term maintenance of change in multiple behaviors (i.e., dietary, physical activity, social support, smoking cessation, and stress management) related to CHD risk, as well as the effects of theoretically important mediating variables on relapse and maintenance. The study is a continuation of a research project that has already demonstrated significant and consistent positive effects of a lifestyle change intervention on reduction of behavioral CHD risk factors. This research relies on a framework that synthesizes social-cognitive, social-ecologic, and goal-systems theories.
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, Coronary Disease
- Medical subject headings
- Diabetes Mellitus, Type 2, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Treatment condition from first study. This is a follow-up study. | |
| 2 | Control condition from first study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food Frequency Questionnaire for Fruits, Vegetables and percent calories from fat (FFQ) by Kristal and colleagues
Measured: annually, 36 months - 84 months
Secondary outcomes (1)
Lipids, weight loss
Measured: annually, 36 months - 84 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2008 (estimated)
- Study startDec 2003
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Deborah J. Toobert, Ph.D., Principal investigator, Oregon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680849
- Sponsor's protocol ID
- HL077120
- Status last verified
- Oct 2011
- First submitted
- 16 May 2008
- Last updated
- 13 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barrera M Jr, Toobert DJ, Angell KL, Glasgow RE, Mackinnon DP. Social support and social-ecological resources as mediators of lifestyle intervention effects for type 2 diabetes. J Health Psychol. 2006 May;11(3):483-95. doi: 10.1177/1359105306063321.
PubMed 16774900Barrera M, Strycker LA, Mackinnon DP, Toobert DJ. Social-ecological resources as mediators of two-year diet and physical activity outcomes in type 2 diabetes patients. Health Psychol. 2008 Mar;27(2S):S118-25. doi: 10.1037/0278-6133.27.2(Suppl.).S118.
PubMed 18377153Greene GW, Nebeling LC, Greaney ML, Lindsay AC, Hardwick CK, Toobert DJ, Resnicow K, Williams GC, Elliot DL, Goldman Sher T, McGregor HA, Domas A, DeFrancesco CA, Peterson KE. A qualitative study of a nutrition working group. Health Promot Pract. 2007 Jul;8(3):299-306. doi: 10.1177/1524839906292587. Epub 2007 May 23.
PubMed 17522413Hellsten LA, Nigg C, Norman G, Burbank P, Braun L, Breger R, Coday M, Elliot D, Garber C, Greaney M, Lees F, Matthews C, Moe E, Resnick B, Riebe D, Rossi J, Toobert D, Wang T. Accumulation of behavioral validation evidence for physical activity stage of change. Health Psychol. 2008 Jan;27(1S):S43-53. doi: 10.1037/0278-6133.27.1(Suppl.).S43.
PubMed 18248105King AC, Toobert D, Ahn D, Resnicow K, Coday M, Riebe D, Garber CE, Hurtz S, Morton J, Sallis JF. Perceived environments as physical activity correlates and moderators of intervention in five studies. Am J Health Promot. 2006 Sep-Oct;21(1):24-35. doi: 10.1177/089011710602100106.
PubMed 16977910Ritzwoller DP, Toobert D, Sukhanova A, Glasgow RE. Economic analysis of the Mediterranean Lifestyle Program for postmenopausal women with diabetes. Diabetes Educ. 2006 Sep-Oct;32(5):761-9. doi: 10.1177/0145721706291757.
PubMed 16971709Strycker LA, Duncan SC, Chaumeton NR, Duncan TE, Toobert DJ. Reliability of pedometer data in samples of youth and older women. Int J Behav Nutr Phys Act. 2007 Feb 17;4:4. doi: 10.1186/1479-5868-4-4.
PubMed 17306031Toobert DJ, Glasgow RE, Strycker LA, Barrera M Jr, Ritzwoller DP, Weidner G. Long-term effects of the Mediterranean lifestyle program: a randomized clinical trial for postmenopausal women with type 2 diabetes. Int J Behav Nutr Phys Act. 2007 Jan 17;4:1. doi: 10.1186/1479-5868-4-1.
PubMed 17229325
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Support for Women With Type 2 Diabetes: Follow-Up
- ClinicalTrials.gov ID
- NCT00680849
- Acronym / sponsor ID
- HL077120
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, Coronary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Dec 2003
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 20 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a 5-year continuation of "The Mediterranean Lifestyle Program." The purpose of this follow-up study is to determine the long-term effects from prior participation in an intervention promoting healthful eating, exercise, quitting smoking, stress management, and social support. Participants are post-menopausal women with type 2 diabetes.
Detailed description
Coronary heart disease (CHD) is the leading cause of death and functional limitations among women in the U.S. Postmenopausal women with diabetes are at especially high risk of CHD, but CHD research with this population is very limited. This project addresses the poorly understood "natural history" of long-term maintenance of change in multiple behaviors (i.e., dietary, physical activity, social support, smoking cessation, and stress management) related to CHD risk, as well as the effects of theoretically important mediating variables on relapse and maintenance. The study is a continuation of a research project that has already demonstrated significant and consistent positive effects of a lifestyle change intervention on reduction of behavioral CHD risk factors. This research relies on a framework that synthesizes social-cognitive, social-ecologic, and goal-systems theories.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Treatment condition from first study. This is a follow-up study. |
| 2 | – | –Control condition from first study. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in prior study: Enhancing Support for Women With Type 2 Diabetes, "The Mediterranean Lifestyle Program."
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Food Frequency Questionnaire for Fruits, Vegetables and percent calories from fat (FFQ) by Kristal and colleagues
Time frame: annually, 36 months - 84 months
1 secondary outcome
Lipids, weight loss
Time frame: annually, 36 months - 84 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2011.
- Background: PubMed 16774900Barrera M Jr, Toobert DJ, Angell KL, Glasgow RE, Mackinnon DP. Social support and social-ecological resources as mediators of lifestyle intervention effects for type 2 diabetes. J Health Psychol. 2006 May;11(3):483-95. doi: 10.1177/1359105306063321.
- Background: PubMed 18377153Barrera M, Strycker LA, Mackinnon DP, Toobert DJ. Social-ecological resources as mediators of two-year diet and physical activity outcomes in type 2 diabetes patients. Health Psychol. 2008 Mar;27(2S):S118-25. doi: 10.1037/0278-6133.27.2(Suppl.).S118.
- Background: PubMed 17522413Greene GW, Nebeling LC, Greaney ML, Lindsay AC, Hardwick CK, Toobert DJ, Resnicow K, Williams GC, Elliot DL, Goldman Sher T, McGregor HA, Domas A, DeFrancesco CA, Peterson KE. A qualitative study of a nutrition working group. Health Promot Pract. 2007 Jul;8(3):299-306. doi: 10.1177/1524839906292587. Epub 2007 May 23.
- Background: PubMed 18248105Hellsten LA, Nigg C, Norman G, Burbank P, Braun L, Breger R, Coday M, Elliot D, Garber C, Greaney M, Lees F, Matthews C, Moe E, Resnick B, Riebe D, Rossi J, Toobert D, Wang T. Accumulation of behavioral validation evidence for physical activity stage of change. Health Psychol. 2008 Jan;27(1S):S43-53. doi: 10.1037/0278-6133.27.1(Suppl.).S43.
- Background: PubMed 16977910King AC, Toobert D, Ahn D, Resnicow K, Coday M, Riebe D, Garber CE, Hurtz S, Morton J, Sallis JF. Perceived environments as physical activity correlates and moderators of intervention in five studies. Am J Health Promot. 2006 Sep-Oct;21(1):24-35. doi: 10.1177/089011710602100106.
- Background: PubMed 16971709Ritzwoller DP, Toobert D, Sukhanova A, Glasgow RE. Economic analysis of the Mediterranean Lifestyle Program for postmenopausal women with diabetes. Diabetes Educ. 2006 Sep-Oct;32(5):761-9. doi: 10.1177/0145721706291757.
- Background: PubMed 17306031Strycker LA, Duncan SC, Chaumeton NR, Duncan TE, Toobert DJ. Reliability of pedometer data in samples of youth and older women. Int J Behav Nutr Phys Act. 2007 Feb 17;4:4. doi: 10.1186/1479-5868-4-4.
- Background: PubMed 17229325Toobert DJ, Glasgow RE, Strycker LA, Barrera M Jr, Ritzwoller DP, Weidner G. Long-term effects of the Mediterranean lifestyle program: a randomized clinical trial for postmenopausal women with type 2 diabetes. Int J Behav Nutr Phys Act. 2007 Jan 17;4:1. doi: 10.1186/1479-5868-4-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah J. Toobert, Ph.D. principal investigator
Oregon Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus, run by Oregon Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food Frequency Questionnaire for Fruits, Vegetables and percent calories from fat (FFQ) by Kristal and colleagues (time frame: annually, 36 months - 84 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00680849, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2011.